Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC
Timeline
- Start
- 2015-07-21
- Primary completion
- 2018-10-04
- Completion
- 2026-12-31
Outcome
Mixed primary results
registry MEDIAN Durvalumab Monotherapy: 16.3 (12.2 to 20.8) months NCT02453282 ↗
registry analysis (superiority test); Durvalumab Monotherapy vs SoC Chemotherapy; p = 0.036; Hazard Ratio (HR) 0.76 (97.54% CI 0.564 to 1.019); Log Rank NCT02453282 ↗
registry analysis (superiority test); Durvalumab + Tremelimumab vs SoC Chemotherapy; p = 0.202; Hazard Ratio (HR) 0.85 (98.77% CI 0.611 to 1.173); Log Rank NCT02453282 ↗
registry MEDIAN Durvalumab + Tremelimumab: 3.9 (2.8 to 5.0) months NCT02453282 ↗
registry MEDIAN SoC Chemotherapy: 5.4 (4.6 to 5.8) months NCT02453282 ↗
registry analysis (superiority test); Durvalumab + Tremelimumab vs SoC Chemotherapy; p = 0.705; Hazard Ratio (HR) 1.05 (99.5% CI 0.722 to 1.534); Log Rank NCT02453282 ↗
Publications
- Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19.
- Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Subject | Durvalumab | Monoclonal antibody | 20 mg/kg | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Pemetrexed | Small molecule | — | — |
| Subject | Tremelimumab | Monoclonal antibody | 1 mg/kg | — |